Mild Cognitive Impairment (MCI)ERCOLENCT07517380
Exercises for Rehabilitation of COgnition and Lifestyle Enhancement in Patients With Mild Cognitive Impairment
A study testing Multimodal Group Cognitive Rehabilitation Intervention in people with Mild Cognitive Impairment (MCI), run by Casa di Cura IGEA at 2 sites in Italy.
Trial summary
Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course characterized by objective cognitive deficits not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment (MCI)
- What is being tested?
- Multimodal Group Cognitive Rehabilitation Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Feb 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MCI according to the diagnostic criteria of Petersen (2004) and Winblad et al. (2004) and, if applicable (i.e., MCI due to AD), according to those of Albert and colleagues (2011).
- Self-reported basic skills in using technological devices, or access to a close person able to provide assistance.
- Willingness of the patient to report, during the study period, any changes in the dosage of psychotropic drugs or other medications that may affect cognition, such as anticholinergics, opioids, benzodiazepines, antidepressants, muscle relaxants, and antiepileptics.
Who cannot join
- Parkinson's disease.
- Linguistic single-domain MCI (suspected onset of primary progressive aphasia).
- Other neurological conditions potentially associated with cognitive impairment (e.g., previous stroke or traumatic brain injury).
- Significant laboratory abnormalities potentially associated with cognitive impairment (e.g., low levels of vitamin B12 or folate, or values indicative of thyroid disorders).
- Primary psychiatric disorders.
- Alcohol or substance use disorder in the previous 10 years.
Show all 11Show fewer
- Severe behavioral disturbances limiting group participation.
- Hearing or visual impairments that may interfere with assessment or treatment.
- Medical conditions that may interfere with completion of the study.
- Exposure, during the study period, to other neuropsychological rehabilitation interventions.
- Patient's refusal to sign the informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Giulia Gilardone Neuropsychologist contact
Italy2 sites, 2 recruiting
- Not yet recruiting
Casa di Cura Igea
Milan, Milano, 20144
Sabrina Guzzetti, +390248593315, s.guzzetti@casadicuraigea.it
Giulia Gilardone, +390248593315, g.gilardone@casadicuraigea.it
- Recruiting
Casa di Cura Igea
Milan, Milan, 20144
Sabrina Guzzetti, Psy.D, +390248593315, s.guzzetti@casadicuraigea.it
Giulia Gilardone, PhD, +390248593315, g.gilardone@casadicuraigea.it
About this study
Official title: Sviluppo di un Intervento di Riabilitazione Cognitiva Applicabile e Sostenibile Nella Pratica Clinica Per i Pazienti Con Mild Cognitive Impairment
Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course characterized by objective cognitive deficits not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. Since MCI represents a risk factor for progression to various forms of dementia, timely preventive intervention is essential, although outpatient cognitive rehabilitation for this population is still limited by issues related to service accessibility.
This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice.
Read more
The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, with the aim of identifying potential predictors of a greater response to the intervention. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire.
The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups, with two 60-minute sessions per week over 12 weeks. The intervention was designed to enhance accessibility and sustainability by limiting intervention intensity and duration, using technology, and delivering group-based rehabilitation in groups that are not highly homogeneous. This approach is expected to result in a better cost-benefit balance and greater transferability to clinical practice. The control group will receive an informational booklet on neuroprotective factors, including practical daily-life recommendations to reduce risk profiles.
Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group. Participants in the experimental group will be further divided into small subgroups based on the presence of memory impairment.
Read the detailed description
Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course, characterized by objective cognitive deficits that are not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. MCI represents a risk factor for progression to dementia: annual conversion rates vary widely across studies, ranging from 2% to 31%, with an average of around 10%. In addition to patients with MCI who progress to dementia, some may show persistent but non-progressive cognitive deficits, while others may even return to normal cognitive functioning, while remaining at higher risk of future cognitive decline. In this context, early diagnosis and timely interventions to reduce the risk of dementia are crucial.
Various interventions have been proposed for the non-pharmacological management of MCI. A review of 14 studies on cognitive rehabilitation in MCI indicated that multimodal interventions and lifestyle-based approaches are the most promising in terms of improving objective cognitive performance (Huckans et al., 2013). Another meta-analysis on 26 studies confirmed the effectiveness of multimodal interventions, as well as multi-domain and memory-specific approaches (Sherman et al., 2017). Other factors, such as MCI subtype, intervention format (individual, group, or computerized), type of control (passive vs. active), follow-up duration (less or more than two weeks), and adjustment for repeated testing showed no appreciable effects on the outcomes. Regarding the dose-response effect of treatment, there is no consensus on the amount of training required for significant benefits. A review and meta-analysis on the relationship between treatment dose (defined by frequency, intensity, and duration) and outcomes found the most robust effects for multi-component approaches delivered 1-2 times per week, 30-60 minutes per session, over a total duration of 8-16 weeks (Shao et al., 2022). Finally, given the increasing role of information and communication technologies in healthcare, cognitive rehabilitation has started to include eHealth tools, which are also suitable for older adults and patients with MCI. Despite the encouraging results reported in the literature, outpatient cognitive rehabilitation for MCI is still limited by issues related to service accessibility.
This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice.
The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, including age, sex, cognitive reserve, MCI subtype, and time since diagnosis, with the aim of identifying potential predictors of a stronger response to the treatment. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire.
The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups formed according to the presence of memory impairment, with two 60-minute sessions per week for a total of 12 weeks. The multimodal approach, including multi-domain cognitive rehabilitation and lifestyle interventions, was selected based on the best available evidence in the literature. A multi-domain format also makes the program well-suited for group delivery, where some heterogeneity in cognitive profiles can still be expected among participants within each subgroup. The limited intervention intensity and duration, the use of technology, and the use of groups not highly homogeneous aimed to enhance accessibility, sustainability and transferability in clinical practice.
The control group will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission, including practical daily-life recommendations to reduce risk.
This study has a mixed design consisting of a between-subjects factor ("Group," with two levels: experimental and control) and a within-subjects factor ("Assessment Time," with three levels: T0, T1, and T2).
To evaluate the effect of the treatment on outcome measures assessing the cognitive, behavioral, and functional profile of patients with MCI, compared with an active control group, a series of repeated-measures analyses of variance (ANOVA) will be performed. In the event of a violation of the assumption of normality, assessed using the Kolmogorov-Smirnov test, either data normalization procedures (e.g., logarithmic transformation) or non-parametric tests (e.g., Kruskal-Wallis) will be adopted.
To explore the relationship between changes in outcome measures in the experimental group and patients' demographic and clinical data, correlations will be conducted between the difference in scores obtained at T0 and T1 and the variables age, cognitive reserve, and time since diagnosis; an independent-samples t-test will be performed for the variable gender; and a one-way ANOVA will be conducted to evaluate the MCI subtype effect.
Sample size was determined through a power analysis conducted with the G*Power software, with a 10% oversampling to compensate for potential dropouts. Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group using stratified randomization based on memory impairment. Participants in the experimental group will be further divided into small subgroups according to the stratification factor.
- Conditions
- Mild Cognitive Impairment (MCI)
- Being tested
- Multimodal Group Cognitive Rehabilitation Intervention, Active Control
- Keywords
- Lifestyle Intervention, Cognitive Training Intervention, Non-pharmacological Intervention, Multicomponent Intervention, Group Cognitive Training Intervention, Multimodal Intervention, Digital Health Intervention, Randomized Controlled Trial
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Group Cognitive Rehabilitation InterventionBehavioural
Also called Multicomponent Group Cognitive Rehabilitation Intervention
The multimodal Group Cognitive Rehabilitation Intervention included a multi-domain cognitive training and a lifestyle intervention. The exercise package adopted in the multi-domain cognitive training will be adapted from that used in a previous cognitive enhancement study by Tagliabue and colleagues (2018) conducted in neurologically healthy adults over 60. The lifestyle intervention will consist of psychoeducational sessions on neuroprotective factor and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups formed according to the presence of memory impairment, with two 60-minute sessions per week for a total of 12 weeks.
Active ControlBehavioural
The control group will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission in 2024, including practical daily-life recommendations to reduce risk. An ad hoc questionnaire will be administered to the patients assigned to the control condition and to one of their family members every two weeks for a period of 12 weeks, in order to monitor patients' efforts and progress in following the recommendations provided.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Group Cognitive Rehabilitation Intervention | Experimental | The experimental group will receive a multimodal group cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention. Receives: Behavioral: Multimodal Group Cognitive Rehabilitation Intervention |
| Active Control Condition | Other | The patients assigned to the active control condition will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission in 2024, including practical daily-life recommendations to reduce risk. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) score
The Montreal Cognitive Assessment (MoCA) is a cognitive test specifically developed for the detection of MCI and is recommended as the preferred tool for screening patients with suspected MCI. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Forward Digit span
It assesses verbal short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Copy of the Modified Taylor Complex Figure
This test evaluates visual-constructional ability. Scores range from 0 to 36, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Rey Auditory Verbal Learning Test (RAVLT)
It evaluates the ability to encode, consolidate, store, recall, and recognize verbal information.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Boston Naming Test (BNT)
It assesses the ability to retrieve the names of visually presented objects.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Multiple Features Target Cancellation (MFTC)
It requires detecting stimuli characterized by a conjunction of visual features, assessing selective attention and visuospatial exploration.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Raven's Colored Progressive Matrices (CPM)
It evaluates nonverbal abstract reasoning.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Semantic and phonemic fluency
It evaluates generative language production under restricted search conditions, thus assessing both language ability and executive functions.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Trail Making Test (TMT)
It assess psychomotor speed, visual attention, and visuomotor coordination in both part A and part B and set-shifting ability in part B.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Weigl sorting test (WST)
It evaluates non verbal executive functions (visual categorization and self monitoring).
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Stroop color word test
It assess inhibition mechanisms.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Questionnaire on lifestyle
It has been developed ad hoc to detect any changes in lifestyle occurring after the intervention.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Forward Corsi span.
It assesses visuo-spatial short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Backward Digit span.
It assesses verbal working memory. Scores range from 0 to 8, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Backward Corsi span
It assesse visuospatial working memory. Scores range from 0 to 8, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Free recall of the Modified Taylor Complex Figure
It assesses visuospatial long-term memory. Scores range from 0 to 36, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Recognition of the Modified Taylor Complex Figure
It assesses visuospatial long-term memory (recognition component). Scores range from 0 to 10, with higher scores indicating better cognitive function.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Secondary outcomes (4)
Functional Activities Questionnaire (FAQ)
It evaluates functional autonomy in complex everyday activities.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Neuropsychiatric Inventory Questionnaire (NPI-q)
It assesses a wide range of neuropsychiatric symptoms.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Geriatric Depression Scale (GDS)
It evaluates depressive symptoms in geriatric population. Scores range from 0 to 30, with scores higher than 9 indicating depressive symptoms.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Self-reported 12-item Short Form questionnaire (SF-12)
It evaluates quolity of life.
Measured: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start16 Feb 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment (MCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Casa di Cura IGEA
- Sponsor type
- University, hospital or other
- Collaborators
- University of Milano Bicocca
- Responsible party
- Sponsor
- Investigators
- Sabrina Guzzetti, Principal investigator, Casa di Cura Igea, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517380
- Sponsor's protocol ID
- CasaCura
- Acronym
- ERCOLE
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Canevelli M, Di Pucchio A, Marzolini F, Mayer F, Massari M, Salvi E, Palazzesi I, Lacorte E, Bacigalupo I, Di Fiandra T, Vanacore N. A National Survey of Centers for Cognitive Disorders and Dementias in Italy. J Alzheimers Dis. 2021;83(4):1849-1857. doi: 10.3233/JAD-210634.
PubMed 34459403Bruscoli M, Lovestone S. Is MCI really just early dementia? A systematic review of conversion studies. Int Psychogeriatr. 2004 Jun;16(2):129-40. doi: 10.1017/s1041610204000092.
PubMed 15318760Huckans M, Hutson L, Twamley E, Jak A, Kaye J, Storzbach D. Efficacy of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: working toward a theoretical model and evidence-based interventions. Neuropsychol Rev. 2013 Mar;23(1):63-80. doi: 10.1007/s11065-013-9230-9. Epub 2013 Mar 8.
PubMed 23471631Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.
PubMed 29282641Shao Z, Hu M, Zhang D, Zeng X, Shu X, Wu X, Kwok TCY, Feng H. Dose-response relationship in non-pharmacological interventions for individuals with mild cognitive impairment: A systematic review and meta-analysis of randomised controlled trials. J Clin Nurs. 2022 Dec;31(23-24):3390-3401. doi: 10.1111/jocn.16240. Epub 2022 Jan 30.
PubMed 35098610Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.
PubMed 15324362Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x.
PubMed 15324367Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
PubMed 39096926Tagliabue CF, Guzzetti S, Gualco G, Boccolieri G, Boccolieri A, Smith S, Daini R. A group study on the effects of a short multi-domain cognitive training in healthy elderly Italian people. BMC Geriatr. 2018 Dec 27;18(1):321. doi: 10.1186/s12877-018-1014-x.
PubMed 30587151Limongi F, Siviero P, Noale M, Gesmundo A, Crepaldi G, Maggi S; Dementia Registry Study Group. Prevalence and conversion to dementia of Mild Cognitive Impairment in an elderly Italian population. Aging Clin Exp Res. 2017 Jun;29(3):361-370. doi: 10.1007/s40520-017-0748-1. Epub 2017 Mar 28.
PubMed 28353219
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sviluppo di un Intervento di Riabilitazione Cognitiva Applicabile e Sostenibile Nella Pratica Clinica Per i Pazienti Con Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT07517380
- Acronym / sponsor ID
- ERCOLE / CasaCura
- Conditions
- Mild Cognitive Impairment (MCI)
- Keywords
- Lifestyle Intervention, Cognitive Training Intervention, Non-pharmacological Intervention, Multicomponent Intervention, Group Cognitive Training Intervention, Multimodal Intervention, Digital Health Intervention, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Casa di Cura IGEAUniversity, hospital or other
- Collaborators
- University of Milano Bicocca
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course characterized by objective cognitive deficits not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. Since MCI represents a risk factor for progression to various forms of dementia, timely preventive intervention is essential, although outpatient cognitive rehabilitation for this population is still limited by issues related to service accessibility.
This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice.
The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, with the aim of identifying potential predictors of a greater response to the intervention. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire.
The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups, with two 60-minute sessions per week over 12 weeks. The intervention was designed to enhance accessibility and sustainability by limiting intervention intensity and duration, using technology, and delivering group-based rehabilitation in groups that are not highly homogeneous. This approach is expected to result in a better cost-benefit balance and greater transferability to clinical practice. The control group will receive an informational booklet on neuroprotective factors, including practical daily-life recommendations to reduce risk profiles.
Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group. Participants in the experimental group will be further divided into small subgroups based on the presence of memory impairment.
Detailed description
Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course, characterized by objective cognitive deficits that are not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. MCI represents a risk factor for progression to dementia: annual conversion rates vary widely across studies, ranging from 2% to 31%, with an average of around 10%. In addition to patients with MCI who progress to dementia, some may show persistent but non-progressive cognitive deficits, while others may even return to normal cognitive functioning, while remaining at higher risk of future cognitive decline. In this context, early diagnosis and timely interventions to reduce the risk of dementia are crucial.
Various interventions have been proposed for the non-pharmacological management of MCI. A review of 14 studies on cognitive rehabilitation in MCI indicated that multimodal interventions and lifestyle-based approaches are the most promising in terms of improving objective cognitive performance (Huckans et al., 2013). Another meta-analysis on 26 studies confirmed the effectiveness of multimodal interventions, as well as multi-domain and memory-specific approaches (Sherman et al., 2017). Other factors, such as MCI subtype, intervention format (individual, group, or computerized), type of control (passive vs. active), follow-up duration (less or more than two weeks), and adjustment for repeated testing showed no appreciable effects on the outcomes. Regarding the dose-response effect of treatment, there is no consensus on the amount of training required for significant benefits. A review and meta-analysis on the relationship between treatment dose (defined by frequency, intensity, and duration) and outcomes found the most robust effects for multi-component approaches delivered 1-2 times per week, 30-60 minutes per session, over a total duration of 8-16 weeks (Shao et al., 2022). Finally, given the increasing role of information and communication technologies in healthcare, cognitive rehabilitation has started to include eHealth tools, which are also suitable for older adults and patients with MCI. Despite the encouraging results reported in the literature, outpatient cognitive rehabilitation for MCI is still limited by issues related to service accessibility.
This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice.
The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, including age, sex, cognitive reserve, MCI subtype, and time since diagnosis, with the aim of identifying potential predictors of a stronger response to the treatment. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire.
The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups formed according to the presence of memory impairment, with two 60-minute sessions per week for a total of 12 weeks. The multimodal approach, including multi-domain cognitive rehabilitation and lifestyle interventions, was selected based on the best available evidence in the literature. A multi-domain format also makes the program well-suited for group delivery, where some heterogeneity in cognitive profiles can still be expected among participants within each subgroup. The limited intervention intensity and duration, the use of technology, and the use of groups not highly homogeneous aimed to enhance accessibility, sustainability and transferability in clinical practice.
The control group will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission, including practical daily-life recommendations to reduce risk.
This study has a mixed design consisting of a between-subjects factor ("Group," with two levels: experimental and control) and a within-subjects factor ("Assessment Time," with three levels: T0, T1, and T2).
To evaluate the effect of the treatment on outcome measures assessing the cognitive, behavioral, and functional profile of patients with MCI, compared with an active control group, a series of repeated-measures analyses of variance (ANOVA) will be performed. In the event of a violation of the assumption of normality, assessed using the Kolmogorov-Smirnov test, either data normalization procedures (e.g., logarithmic transformation) or non-parametric tests (e.g., Kruskal-Wallis) will be adopted.
To explore the relationship between changes in outcome measures in the experimental group and patients' demographic and clinical data, correlations will be conducted between the difference in scores obtained at T0 and T1 and the variables age, cognitive reserve, and time since diagnosis; an independent-samples t-test will be performed for the variable gender; and a one-way ANOVA will be conducted to evaluate the MCI subtype effect.
Sample size was determined through a power analysis conducted with the G*Power software, with a 10% oversampling to compensate for potential dropouts. Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group using stratified randomization based on memory impairment. Participants in the experimental group will be further divided into small subgroups according to the stratification factor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Group Cognitive Rehabilitation Intervention | Experimental | Behavioral: Multimodal Group Cognitive Rehabilitation InterventionThe experimental group will receive a multimodal group cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention. |
| Active Control Condition | Other | Behavioral: Active ControlThe patients assigned to the active control condition will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission in 2024, including practical daily-life recommendations to reduce risk. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of MCI according to the diagnostic criteria of Petersen (2004) and Winblad et al. (2004) and, if applicable (i.e., MCI due to AD), according to those of Albert and colleagues (2011).
- Self-reported basic skills in using technological devices, or access to a close person able to provide assistance.
- Willingness of the patient to report, during the study period, any changes in the dosage of psychotropic drugs or other medications that may affect cognition, such as anticholinergics, opioids, benzodiazepines, antidepressants, muscle relaxants, and antiepileptics.
Key exclusion criteria (11 listed)
- Parkinson's disease.
- Linguistic single-domain MCI (suspected onset of primary progressive aphasia).
- Other neurological conditions potentially associated with cognitive impairment (e.g., previous stroke or traumatic brain injury).
- Significant laboratory abnormalities potentially associated with cognitive impairment (e.g., low levels of vitamin B12 or folate, or values indicative of thyroid disorders).
- Primary psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Group Cognitive Rehabilitation InterventionAlso: Multicomponent Group Cognitive Rehabilitation InterventionThe multimodal Group Cognitive Rehabilitation Intervention included a multi-domain cognitive training and a lifestyle intervention. The exercise package adopted in the multi-domain cognitive training will be adapted from that used in a previous cognitive enhancement study by Tagliabue and colleagues (2018) conducted in neurologically healthy adults over 60. The lifestyle intervention will consist of psychoeducational sessions on neuroprotective factor and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups formed according to the presence of memory impairment, with two 60-minute sessions per week for a total of 12 weeks. | Behavioural | Multimodal Group Cognitive Rehabilitation Intervention |
| Active ControlThe control group will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission in 2024, including practical daily-life recommendations to reduce risk. An ad hoc questionnaire will be administered to the patients assigned to the control condition and to one of their family members every two weeks for a period of 12 weeks, in order to monitor patients' efforts and progress in following the recommendations provided. | Behavioural | Active Control Condition |
Primary outcome
Montreal Cognitive Assessment (MoCA) score
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
The Montreal Cognitive Assessment (MoCA) is a cognitive test specifically developed for the detection of MCI and is recommended as the preferred tool for screening patients with suspected MCI. Scores range from 0 to 30, with higher scores indicating better cognitive function.
Forward Digit span
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesses verbal short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.
Copy of the Modified Taylor Complex Figure
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
This test evaluates visual-constructional ability. Scores range from 0 to 36, with higher scores indicating better cognitive function.
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It evaluates the ability to encode, consolidate, store, recall, and recognize verbal information.
Boston Naming Test (BNT)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesses the ability to retrieve the names of visually presented objects.
Multiple Features Target Cancellation (MFTC)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It requires detecting stimuli characterized by a conjunction of visual features, assessing selective attention and visuospatial exploration.
Raven's Colored Progressive Matrices (CPM)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It evaluates nonverbal abstract reasoning.
Semantic and phonemic fluency
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It evaluates generative language production under restricted search conditions, thus assessing both language ability and executive functions.
Trail Making Test (TMT)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assess psychomotor speed, visual attention, and visuomotor coordination in both part A and part B and set-shifting ability in part B.
Weigl sorting test (WST)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It evaluates non verbal executive functions (visual categorization and self monitoring).
Stroop color word test
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assess inhibition mechanisms.
Questionnaire on lifestyle
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It has been developed ad hoc to detect any changes in lifestyle occurring after the intervention.
Forward Corsi span.
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesses visuo-spatial short-term memory. Scores range from 0 to 9, with higher scores indicating better cognitive function.
Backward Digit span.
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesses verbal working memory. Scores range from 0 to 8, with higher scores indicating better cognitive function.
Backward Corsi span
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesse visuospatial working memory. Scores range from 0 to 8, with higher scores indicating better cognitive function.
Free recall of the Modified Taylor Complex Figure
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesses visuospatial long-term memory. Scores range from 0 to 36, with higher scores indicating better cognitive function.
Recognition of the Modified Taylor Complex Figure
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
It assesses visuospatial long-term memory (recognition component). Scores range from 0 to 10, with higher scores indicating better cognitive function.
4 secondary outcomes
Functional Activities Questionnaire (FAQ)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Neuropsychiatric Inventory Questionnaire (NPI-q)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Geriatric Depression Scale (GDS)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Self-reported 12-item Short Form questionnaire (SF-12)
Time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 34459403Canevelli M, Di Pucchio A, Marzolini F, Mayer F, Massari M, Salvi E, Palazzesi I, Lacorte E, Bacigalupo I, Di Fiandra T, Vanacore N. A National Survey of Centers for Cognitive Disorders and Dementias in Italy. J Alzheimers Dis. 2021;83(4):1849-1857. doi: 10.3233/JAD-210634.
- Background: PubMed 15318760Bruscoli M, Lovestone S. Is MCI really just early dementia? A systematic review of conversion studies. Int Psychogeriatr. 2004 Jun;16(2):129-40. doi: 10.1017/s1041610204000092.
- Background: PubMed 23471631Huckans M, Hutson L, Twamley E, Jak A, Kaye J, Storzbach D. Efficacy of cognitive rehabilitation therapies for mild cognitive impairment (MCI) in older adults: working toward a theoretical model and evidence-based interventions. Neuropsychol Rev. 2013 Mar;23(1):63-80. doi: 10.1007/s11065-013-9230-9. Epub 2013 Mar 8.
- Background: PubMed 29282641Sherman DS, Mauser J, Nuno M, Sherzai D. The Efficacy of Cognitive Intervention in Mild Cognitive Impairment (MCI): a Meta-Analysis of Outcomes on Neuropsychological Measures. Neuropsychol Rev. 2017 Dec;27(4):440-484. doi: 10.1007/s11065-017-9363-3. Epub 2017 Dec 27.
- Background: PubMed 35098610Shao Z, Hu M, Zhang D, Zeng X, Shu X, Wu X, Kwok TCY, Feng H. Dose-response relationship in non-pharmacological interventions for individuals with mild cognitive impairment: A systematic review and meta-analysis of randomised controlled trials. J Clin Nurs. 2022 Dec;31(23-24):3390-3401. doi: 10.1111/jocn.16240. Epub 2022 Jan 30.
- Background: PubMed 15324362Petersen RC. Mild cognitive impairment as a diagnostic entity. J Intern Med. 2004 Sep;256(3):183-94. doi: 10.1111/j.1365-2796.2004.01388.x.
- Background: PubMed 15324367Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x.
- Background: PubMed 39096926Livingston G, Huntley J, Liu KY, Costafreda SG, Selbaek G, Alladi S, Ames D, Banerjee S, Burns A, Brayne C, Fox NC, Ferri CP, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Nakasujja N, Rockwood K, Samus Q, Shirai K, Singh-Manoux A, Schneider LS, Walsh S, Yao Y, Sommerlad A, Mukadam N. Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet. 2024 Aug 10;404(10452):572-628. doi: 10.1016/S0140-6736(24)01296-0. Epub 2024 Jul 31. No abstract available.
- Background: PubMed 30587151Tagliabue CF, Guzzetti S, Gualco G, Boccolieri G, Boccolieri A, Smith S, Daini R. A group study on the effects of a short multi-domain cognitive training in healthy elderly Italian people. BMC Geriatr. 2018 Dec 27;18(1):321. doi: 10.1186/s12877-018-1014-x.
- Background: PubMed 28353219Limongi F, Siviero P, Noale M, Gesmundo A, Crepaldi G, Maggi S; Dementia Registry Study Group. Prevalence and conversion to dementia of Mild Cognitive Impairment in an elderly Italian population. Aging Clin Exp Res. 2017 Jun;29(3):361-370. doi: 10.1007/s40520-017-0748-1. Epub 2017 Mar 28.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giulia Gilardone Neuropsychologist contact
Sabrina Guzzetti principal investigator
Casa di Cura Igea, Milano
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Group Cognitive Rehabilitation Intervention in people with Mild Cognitive Impairment (MCI), run by Casa di Cura IGEA at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Guzzetti Neuropsychologist (+390248593315, s.guzzetti@casadicurigea.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) score (time frame: Data will be collected at T0 (baseline), T1 (upon completion of the 12-week treatment), and T2 (six months after baseline).). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07517380, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.